Angioplasty device and method of making same

ABSTRACT

An angioplasty device and particle trap for use in removal of a particle from a small diameter vessel or vessel-like structure is disclosed. One embodiment includes a catheter for insertion into a vessel-like structure, the catheter having a catheter wall and a movable member, a trap operably connected to the catheter wall and to the movable member, wherein relative motion between the catheter wall and the movable member actuates the trap. In one embodiment, the expanded trap is formed from struts in a spiral-shaped configuration. In one embodiment, the contracted trap forms a waist to creates a pinch-point to trap particles. In one embodiment, the contracted trap forms a cocoon-like structure to further trap particles. In one embodiment, the angioplasty device includes a handle to actuate the trap from a contracted position to an expanded position and return to a contracted position. The handle provides rotational or longitudinal or both types of movement to actuate the trap.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation-in-part of U.S. patent applicationSer. No. 09/718,732, filed Nov. 22, 2000 which is a continuation-in-partof U.S. patent application Ser. No. 09/495,833, filed Feb. 1, 2000, bothof which are herein incorporated by reference.

TECHNICAL FIELD

This invention relates to an angioplasty device for compressing and/orremoving atherosclerotic plaques, thromboses, stenoses, occlusions,clots, potential embolic material and so forth (hereinafter“obstructions”) from veins, arteries, vessels, ducts and the like(hereinafter “vessels”). More particularly, the invention relates to atotal capture angioplasty device and trap capable of use in small andlarge diameter vessels and vessel-like structures.

BACKGROUND OF THE INVENTION

Angioplasty devices are used to treat a wide variety of conditions andto perform a wide variety of procedures, including without limitation:congenital or acquired stenoses or obstructions; percutaneous aspirationthromboembolectomy; cerebral embolization; congenital or acquiredobstruction or stenosis of the aorta, renal, coronary, pulmonary, iliac,femoral, popliteal, peroneal, dorsalis pedis, subclavian, axillary,brachial, radial, ulnar, vertebral, cerebral and/or cerebellar artery orany other accessible artery or their ramifications; congenital oracquired obstruction or stenosis of the superior vena cava, inferiorvena cava, common iliac, internal iliac, external iliac, femoral,greater saphenous, lesser saphenous, posterior tibial, peroneal,popliteal, pulmonary, coronary, coronary sinus, innominate, brachial,cephalic, basilic, internal jugular, external jugular, cerebral,cerebellar, sinuses of the dura mater and/or vertebral vein or any otheraccessible vein or their ramifications; atheromatous lesions of anygraft or its ramifications; obstructions or stenoses of connectionsbetween and among grafts, veins, arteries, organs and ducts; vena cavalbleeding; congenital or acquired intracardiac obstructions, stenoses,shunts and/or aberrant communications; congenital or acquiredcardiovascular obstructions, stenoses and/or diseases; infusion ofthrombolytic agents; thromboembolic phenomena; diagnosticcatheterization; removal of clots; intrahepatic and/or extrahepaticbiliary ductal obstructions (e.g., stones, sediment or strictures);intravascular, intracardiac and/or intraductal foreign bodies; renaldialysis; congenital and acquired esophageal and/or gastrointestinalobstructions and/or stenoses; non-organized atheromata; dialysis fistulastenosis; ruptured cerebral aneurysm; arterio-arterial, arteriovenousand/or veno-venous fistulae; ureteral obstructions (e.g., stones,sediment or strictures); fibromuscular dysplasia of the renal artery,carotid artery and/or other blood vessels; and/or atherosclerosis of anyaccessible artery, vein or their ramifications. Such procedures may beperformed in both humans and in other applications.

Conventional angioplasty devices generally consist of a cathetercontaining a balloon-like member that is inserted into an occludedvessel. Expansion of the balloon at the obstruction site crushes theobstruction against the interior lining of the vessel. When the balloonis retracted, the obstruction remains pressed against the vessel walland the effective diameter of the vessel through which fluid may flow isincreased at the site of the obstruction. Examples of angioplastydevices incorporating a balloon are shown in U.S. Pat. Nos. 4,646,742;4,636,195; 4,587,975; and 4,273,128.

Other conventional angioplasty devices have been developed thatincorporate expandable meshes or braids, drilling or cutting members, orlasers as a means for removing an obstruction. Examples of theseangioplasty devices are illustrated by U.S. Pat. Nos. 4,445,509;4,572,186; 4,576,177; 4,589,412; 4,631,052; 4,641,912; and 4,650,466.

Many problems have been associated with these angioplasty devices.Perhaps the most significant problem is the creation of particulatematter during the obstruction removal procedure. Recent ex vivo studieshave demonstrated that huge numbers of emboli are produced on inflationand on deflation of the angioplasty balloon during dilation of astenotic lesion. See Ohki T. Ex vivo carotid stenting, (Presentation)ISES International Congress XI, Feb. 11, 1998. These particles arereleased into the fluid flowing through the vessel and can lead toemboli, clots, stroke, heart failure, hypertension and decreased renalfunction, acute renal failure, livedo reticularis and gangrene of thelower extremities, abdominal pain and pancreatitis, cerebral infarctionand retinal emboli, tissue injury, tissue death, emergency bypasssurgery, death and other undesirable side effects and complications.Regardless of the type of angioplasty device used, a substantial numberof particles will be generated.

Even very small particles can cause significant harm. Thecross-sectional diameter of normal capillaries varies for differentparts of the body and may be comprised of vessels as small as 2.0-3.5μfor very thin capillaries or 3.5-5.0μ for moderately thin capillaries.Accordingly, any particles that exceed these sizes can lodge inside thevessel. Furthermore, in the case of the heart, approximately 45% of thecapillaries are closed at any given time, so that any particle, nomatter how small, dislodged into this organ is liable to capture.Accordingly, it has become apparent that distal embolization presents aformidable threat.

One partial solution to the above-noted problems is disclosed in U.S.Pat. No. 4,794,928 to Kletschka. This angioplasty device incorporates atrap/barrier for trapping and removing particles that break away fromthe treatment sight. This device is desirable because it can preventphysiologically significant particles from escaping from the obstructionsite, thus preventing the occurrence of unfavorable side effects fromangioplasty treatment and procedures. One problem with this design,however, is that it is difficult to simultaneously provide anangioplasty device that is small enough to be used in very small andmedium sized arteries, and/or in severely occluded vessels (i.e.,vessels having a 90% or greater stenosis), and that has sufficientsuction to remove the particulate matter.

Another partial solution to the above noted problems uses multiplecatheters. These devices require that the doctor first deliver a“blocking” catheter to the target region such that its occlusion balloonis distal to the treatment site. The doctor then loads a second“balloon” catheter over the blocking catheter and performs theangioplasty procedure. The second catheter is then removed and a thirdcatheter is loaded in its place over the blocking catheter. The thirdcatheter can be used to aspirate blood from the treatment site. Oneproblem with this design, however, is that it does not provide a meansfor capturing particles that are too large to fit within the suctionlumen. Another problem is that this design requires a complex andrelatively lengthy operational procedure, which can lead to neurologicalcomplications. In addition, particulate matter may also escape or bepulled from the treatment site when the catheters are switched and whenthe blocking balloon is deflated. Even when combined with suction, therisk exists that particles too large to be removed through the suctionconduit will be delivered distally from the forward thrust of the bloodflow as the blocking balloon is deflated.

Still another partial solution uses a porous hood that allows blood topass. The hood, attached to the guidewire with struts, is held in acollapsed state within the angioplasty catheter. The hood deploys whenpushed beyond the tip of the restraining catheter. Withdrawing the hoodwithin the catheter closes the trap. These devices, however, do notprovide suction and require multiple catheters. In addition, smallparticles may pass through the porous hood.

FIG. 1 illustrates the problems associated with obtaining the size ofconduits necessary to do just the desired insertion, inflation, andsuction tasks. FIG. 1 is a cross section of a five French catheter 10. Astandard, 150 centimeter long, catheter may need a suction lumen 12 witha diameter of about 0.025 inches in order provide sufficient suction atits operational end to cope with debris released from a largeatheromatous plaque. The catheter may also require aninflation/deflation lumen 14 with a diameter of about 0.015 inches toinflate an angioplasty balloon and a centered guidewire lumen 16 havinga diameter of about 0.035 inches to position the device. As can be seen,these lumens significantly interfere with each other. An additionalmechanism to open and close a blocking/capturing device will furtherencroach on allocatable space.

Clearly, there is a need for an improved angioplasty device for use insmall diameter and/or severely occluded vessels that can preventsubstantially all physiologically significant particles from escapingfrom the obstruction site, thus preventing the occurrence of unfavorableside effects from the angioplasty treatment and procedures. There isalso a need for a small diameter angioplasty device that can provideaspiration, blocking, and capturing capabilities. In addition, there isa need for an improved particle trap that can prevent substantially allphysiologically significant particles from escaping from the obstructionsite and that can fit within, and be actuated by, a small diametercatheter bundle. There is also a need for an improved particle trapwherein the improved particle trap provides better maneuveringcapabilities and more flexible navigation capabilities within vessels.There is a need for a method of making an improved particle trap withenhanced maneuvering capabilities. There is also a need for a trap withenhanced trapping capabilities for collecting and capturing particleswhile the trap is in the contracted position. There is a need for ahandle device which operates to actuate the particle trap and whichincorporates a locking mechanism for securing the particle trap ineither the expanded or contracted position.

BRIEF SUMMARY OF THE INVENTION

The present invention provides an apparatus for use in angioplastyprocedures or other medical, veterinary, non-medical or industrialapplications where removal of an obstruction from a vessel orvessel-like structure could produce particles, which, if allowed toremain in the vessel, could cause undesirable complications and results.The present invention is particularly suited for use in small diametervessels and/or in severely occluded vessels because it maximizes suctionfor a given catheter diameter. The present invention can also preventsubstantially all physiologically significant particles from escapingfrom the obstruction site. Particles smaller than the width of thesuction lumen are removed by aspiration in some embodiments, while thelarger particles are captured beneath a contractible hood and removedwhen the catheter is withdrawn. Some embodiments also have a provisionfor aspirating debris generated as the angioplasty device is insinuatedthrough a stenosis.

One aspect of the present invention is an angioplasty device forremoving an obstruction from a vessel or vessel-like structure. Oneembodiment of this angioplasty device comprises a catheter for insertioninto a vessel-like structure and a trap operably connected to thecatheter and to a rotatable member, such as a fixed guidewire or acatheter forming a longitudinal axis, wherein a rotation of therotatable member relative to the catheter actuates the trap. Someembodiments of this angioplasty device may also comprise a flexiblestrut fixedly connected to the catheter and to the trap. This flexiblestrut may expand and contract the trap by moving between a helicallytwisted position and an arcuately expanded position.

In one embodiment of the angioplasty device, the arcuately expandedposition of the struts may form arcs that extend parallel to thelongitudinal axis of the catheter or guidewire. In another embodiment,the expanded position of the struts forms arcs in a spiral configurationthat circle the longitudinal axis of the catheter or guidewire. Otherarcuately expanded positions of the struts are within the scope of thisinvention so long as the function of the trap is performed.

In one embodiment, the mid-section begins to close first to create awaist in the contracted trap. In this embodiment, the waist creates apinch-point to enhance the trapping capabilities of the trap.

In another embodiment, one end of the trap is less resistant to closurethan the other end of the trap, so that in contracting the trappingdevice, the less resistant section will close first. In this embodiment,the less resistant section will close tightly down while the othersection will retain a small pocket. The overall profile of thecontracted trap forms a cocoon-like structure in the shape of ateardrop.

Another aspect of this invention is a trap for selectively blocking avessel or vessel-like structure. One embodiment comprises a rotatablemember, such as a fixed guidewire or a catheter, that actuates aflexible strut between an arcuately expanded position and a helicallytwisted position, and a membrane operably connected to the flexiblestrut. These embodiments may further comprise a first ring that fixedlyconnects the rotational member to the flexible strut and a second ringthat fixedly connects the flexible strut to a catheter. In addition, theproximal portion of the flexible struts can be inserted into the wall ofthe catheter in place of or in addition to the second ring.

Another aspect of the present invention are methods of making a particletrap adapted for removing an obstruction from a vessel-like structure.One embodiment comprises the acts of operably connecting a plurality offlexible struts to an outer surface of a catheter, the cathetercontaining a rotatable member; operably connecting the plurality offlexible struts to the rotatable member; and operably connecting amembrane to the plurality of flexible struts.

Another aspect of the present invention is a method of forming flexiblestruts for use in making the particle trap. In one embodiment ashape-memory alloy is used to form the struts in the steady-stateexpanded position. In another embodiment a polymer or plastic materialis used to form the struts into the steady-state expanded position. Thestruts may be formed by fixedly attaching each end of the strut to astationary device and shaping the struts over a molded device in theprofile desired for the steady-state expanded position. The shape-memoryalloy would then be treated so that it forms the profile of the moldeddevice for its steady-state expanded position. In one embodiment, heattreatment is used to treat the metal to form the expanded profile. Inone embodiment, the expanded spiral configuration is formed using amolded device in the desired profile wherein a portion of the moldeddevice rotates to form a spirally twisted position of the expandedstrut. The struts are then treated to form the spirally twistedposition.

Another aspect of the present invention is a device for removing anobstruction from a vessel-like structure. One embodiment comprises acatheter for insertion into a vessel-like structure, the catheter havinga catheter wall and a movable member, and a trap operably connected tothe catheter wall and to the movable member. Relative motion between thecatheter wall and the movable member actuates the trap. This relativemotion may be a relative rotation or a relative translation.

In one embodiment, the angioplasty device comprises a handle fixed tothe angioplasty device which the user manipulates to actuate the trap.The handle comprises a thumbwheel and a screw configuration enabling theuser to actuate the trap from the contracted position to the expandedposition. In one embodiment the handle comprises a lock for locking thetrap in the desired position depending on the particular steps of theprocedure. In these embodiments, the handle provides the necessaryrelative rotational or longitudinal or both movements to actuate thetrap.

Another aspect is a catheter bundle for insertion into a vessel-likestructure. The catheter bundle in this embodiment defines a balloonadapted to compress an obstruction against the vessel-like structure; atrap adapted to selectively block the vessel-like structure; aninflation lumen in operable communication with the balloon; and asuction lumen in operable communication with the trap. This catheterbundle has a diameter of less than about twenty French, with someembodiments having a diameter of less than about five French.

Another aspect of the present invention is a type of angioplastyprocedure. One embodiment of this procedure comprises the acts ofinserting a catheter into the vessel-like structure, the catheterincluding a trap and an actuator; positioning the trap in a downstreamdirection from an obstruction; moving the actuator in a first direction,thereby opening the trap; and moving the actuator in a second direction,thereby closing the trap. This procedure may further comprise the act ofremoving the obstruction from the vessel-like structure, therebyproducing at least one particle. The at least one particle may beremoved from the vessel-like structure using a suction lumen, the trap,or a combination thereof.

Three additional aspects of the present invention are a modular trap foran angioplasty device, a guidewire for use in a medical device, and anangioplasty device having a valve. One modular trap embodiment comprisesa trap adapted to selectively block a vessel-like structure; and acoupling device that couples the trap to the angioplasty device. Oneguidewire embodiment comprises a guidewire wall defining a proximalopening, a distal opening, and an annular passageway, wherein theannular passageway fluidly connects the proximal opening to the distalopening. One angioplasty device embodiment with a valve comprises afirst lumen, and a valve adapted to selectively block the first lumen.

Another aspect of the present invention is an apparatus for insertioninto a vessel-like structure over a guidewire. One embodiment comprisesa catheter for insertion into a vessel-like structure, the catheterhaving a catheter wall and a movable member, and a trap operablyconnected to the catheter wall and to the movable member, whereinrelative motion between the catheter wall and the movable memberactuates the trap. The catheter in this embodiment includes a guidewirelumen adapted to slideably receive the guidewire.

The present invention also includes a method of making an angioplastydevice suitable for over the wire procedures. One embodiment comprisesforming a catheter having a first wall and a second wall, operablyconnecting a plurality of flexible struts to the first wall, operablyconnecting the plurality of flexible struts to the second wall, andoperably connecting a membrane to the plurality of flexible struts. Thefirst wall in this embodiment defines a guidewire lumen and cooperateswith the second wall to define a fluid communication lumen.

One or more of these embodiments may be used to remove an obstructionfrom a vessel-like structure by inserting the guidewire into avessel-like structure; inserting a catheter into the vessel-likestructure over the guidewire, the catheter including a trap and anactuator; positioning the trap in a downstream direction from anobstruction; moving the actuator in a first direction, thereby openingthe trap; and moving the actuator in a second direction, thereby closingthe trap.

One feature and advantage of the present invention is that it canprovide a small diameter angioplasty device that can trap and removesubstantially all physiologically significant particles. Another featureand advantage of the present invention is that it can provideaspiration, blocking, and capturing capabilities in a single catheter.Yet another feature and advantage is that the present inventionmaximizes the amount of suction per unit size, thus providing the doctorwith more suction in larger vessels than presently available. These andother features, aspects, and advantages of the present invention willbecome better understood with reference to the following description,appended claims, and accompanying drawings.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. As will be realized, theinvention is capable of modifications in various obvious aspects, allwithout departing from the spirit and scope of the present invention.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 (prior art) is a sectional view illustrating the size limits of aconventional five French catheter.

FIG. 2 is a side view of one embodiment of the angioplasty device of thepresent invention.

FIGS. 3A-3C are side plan views of different trap embodiments.

FIG. 4 is a sectional view of the embodiment depicted in FIG. 2 takenalong the line AA.

FIG. 5 is a side view of the distal end of the embodiment depicted inFIG. 2.

FIG. 6 is a sectional view of the embodiment depicted in FIG. 5, takenalong the line CC.

FIG. 7A is a perspective view of an embodiment having a plurality ofstruts in a helically twisted position, with portions of the strutsremoved to show the inner catheter wall.

FIG. 7B is a side plan view of an embodiment having a plurality ofstruts in an arcuately expanded position.

FIG. 7C is a side plan view of an embodiment having a plurality ofstruts in an arcuately expanded position with the arcs forming a spiralconfiguration.

FIG. 7D is a side plan view of an embodiment of a profile devices.

FIG. 7E is a side plan view of an embodiment having a plurality ofstruts in a contracted position wherein the contracted trap has formed awaist.

FIG. 7F is a side plan view of an embodiment having a plurality ofstruts in a contracted position wherein the contracted trap has formed acocoon.

FIG. 7G is a side plan view of an embodiment having a plurality ofstruts in a contracted position wherein the contracted trap has formed acocoon.

FIG. 8 is a sectional view of a stiffener, taken along the line BB.

FIGS. 9A and 9B are a sectional view and a side plan view of anembodiment having a screw extension system.

FIG. 10 is a detailed side plan view of an embodiment having a flexiblemembrane extension system.

FIG. 11A is a side plan view of an embodiment capable of providingsuction during insertion.

FIGS. 11B and 11C are side plan views of two disks for use with theembodiment in FIG. 11A.

FIGS. 12A and 12B are sectional views of an alternate valve embodiment.

FIG. 13 is a side plan view of an embodiment having separate cathetersfor the trap and the operative member.

FIG. 14 is a sectional view of a trap catheter bundle embodimentconfigured for use in the antegrade direction.

FIG. 15 is a sectional view of a trap catheter bundle embodimentconfigured for use in the retrograde direction.

FIG. 15A is a section view of a trap catheter bundle with a stepped-upsuction lumen.

FIG. 15B is a section view of a trap catheter bundle with a guidewirehaving a solid portion and a suction lumen.

FIG. 16 is a sectional view of a trap catheter bundle embodimentconfigured for use in the antegrade direction, in which the trap isactuated by relative motion between an inner catheter wall and an outercatheter wall.

FIG. 17 is a sectional view of a trap catheter bundle embodimentconfigured for use in the retrograde direction, in which the trap isactuated by relative motion between an inner catheter wall and an outercatheter wall.

FIG. 18A is a sectional view of an angioplasty device embodimentconfigured for use in the retrograde direction in which the trap isactuated by relative motion between an inner catheter wall and an outercatheter wall.

FIG. 18B is a sectional view of an angioplasty device embodimentconfigured for use in the antegrade direction in which the trap isactuated by relative motion between an inner catheter wall and an outercatheter wall.

FIG. 19 is a sectional view of an angioplasty device embodiment having acoupling device.

FIG. 20 is a sectional view of the coupling device in FIG. 19.

FIG. 21 is a sectional view of a trap actuated by a relativetranslation, showing the trap in an arcuately expanded position.

FIG. 22 is a sectional view of the trap in FIG. 21, showing the trap ina contracted position.

FIGS. 23A is a sectional view of a modular trap embodiment.

FIGS. 23B, 24A, and 24B are sectional views of alternate modular trapembodiments.

FIG. 25 is a sectional view of an embodiment having a hollow guidewire.

FIG. 26 is a sectional view of an alternate embodiment having a hollowguidewire.

FIG. 27 is a sectional view of an embodiment in which a plurality ofstruts connect a coupling device to the angioplasty catheter.

FIG. 28 is a sectional view of the angioplasty device in FIG. 5.

FIG. 29 is a detailed sectional view of an alternate proximal endembodiment.

FIG. 30 is a sectional view of a modular trap embodiment having aguidewire lumen.

FIG. 31 is a sectional view of a profile device for forming expandedstruts.

FIG. 32 is an assembly view of the handle.

FIG. 33A-E are a sectional views of a trap and a profile device forforming expanded struts from a tube.

FIG. 34A-C are sectional views of a trap formed from a tube with thestruts varying in thickness.

DETAILED DESCRIPTION

FIG. 2 is a side plan view of one embodiment of the angioplasty device20 of the present invention. This angioplasty device 20 comprises aflexible catheter 26 having a proximal end 22, a distal end 24, and agenerally circular cross section. The proximal end 22 of the catheter 26is connected to a branched housing 28 that contains a suction port 30,an inflation port 32, and a guidewire port 34. The distal end 24 of thecatheter 26 is connected to an angioplasty balloon 36, and atrap/barrier 38. As will be described in more detail with reference toFIG. 4, the flexible catheter 26 contains an inflation/deflation lumen40, a suction/vacuum lumen 42, and a flexible guidewire 44.

In operation, distal end 24 of the angioplasty device 20 may be insertedinto a vessel at any point in relation to the treatment site that isconsistent with the desired treatment protocol. The balloon 36 is thenaligned with the obstruction using methods known in the art, such as aradiopaque contrast solution, so that the trap 38 is situated in aposition downstream from the obstruction site with the opening of thetrap 38 positioned so that the fluid will flow into it and beneath thehood/membrane.

After positioning, the trap 38 may be expanded so that it forms a sealagainst the inner lining of the vessel. This seal will preventphysiologically significant particles from leaving the treatment site. Afluid, air, or other expansion medium may be then injected into thedevice 20 through the inflation port 32 and may be delivered through thelumen 40 to the balloon 36. The balloon 36 may then be expanded toperform its function. Alternatively, the balloon 36 and the trap 38 maybe expanded simultaneously or the balloon could be expanded before thetrap 38. As the balloon 36 is expanded, the obstruction is crushedagainst the inner diameter of the vessel, which increases the areathrough which fluid can flow. Crushing of the obstruction, however,creates particles that may break free on either side of the balloon 36.

When the vessel is living tissue (e.g., a human or animal vein, arteryor duct) the balloon 36 may be inflated to a pressure ranging fromapproximately three to fifteen atmospheres, or more, depending on theapplication. The proper pressure will be dependant on the treatmentprotocol, the type of organism being treated, the type of vessel beingtreated and the material from which the balloon is constructed.Appropriate expansion pressures for a given situation will be known tothose skilled in the art.

The balloon 36 may then be partially retracted so that a pressuredifferential between the vessel and the suction lumen 42 can draw anyresulting particles toward the trap 38. Particles are either drawn intoand through the catheter 26 or lodged in the trap 38 such that, when thetrap 38 is retracted, the particles are trapped inside.

The trap 38 in this embodiment may assume any final shape as long as asubstantial seal is achieved with the inner lining of the vessel to betreated and so long as the shape facilitates entrapment of theparticles. FIGS. 3A-3C show three possible trap 38 embodiments. Inparticular, FIG. 3A shows a generally conically shaped trap 38, FIG. 3Bshows a more or less “egg” shaped trap 38, and FIG. 3C shows a more orless oval shaped trap 38. Other trap 38 shapes and configurations arealso within the scope of the present invention. In addition, the trap 38and the balloon 36 may be situated with respect to each other in anyconfiguration that allows the trap 38 to achieve a seal with the innervessel lining and to trap particles when expanded. This includes,without being limited to, configurations in which the relative locationsof the balloon 36 and the trap 38 are reversed. In contrast with the“antegrade” embodiments depicted in FIGS. 2 and 3A-3C, these“retrograde” embodiments would allow insertion of the angioplasty devicefrom a point “downstream” from the treatment site.

Those skilled in the art will recognize that the balloon 36 in thisembodiment serves as an operative member and may be replaced by anymeans known in the art, or later developed in the art, for removing orcompressing an obstruction. Thus, as used throughout this specificationand the claims, the terms “balloon” and “operative member” encompass anymeans for removing or compressing an obstruction, including but notlimited to balloons, meshes, cutting rotors, lasers, treatment agents,and the means represented by U.S. Pat. Nos. 4,646,742, 4,636,195,4,587,975, 4,273,128, 4,650,466, 4,572,186, 4,631,052, 4,589,412,4,445,509, 4,641,912 and 4,576,177, the disclosures of which areincorporated herein by reference. Each type of operative member willhave its unique control mechanism that, in the case of a balloon, fillsit or, in the case of a laser or cutting rotor, turns it on.Furthermore, although the balloon and its associated filling orexpansion system will be used throughout the specification as an exampleof an operative member and its associated control means, it is to beunderstood that any available operative member and its control meanscould be substituted in many of the embodiments discussed herein. Thus,references to “expansion” and “retraction” of the balloon should beunderstood, by inference, to refer to activating and deactivatingwhatever operative member is incorporated into a given angioplastydevice 20.

FIG. 4 is a sectional view of the catheter 26 in FIG. 2 taken along lineAA. The catheter 26 includes an outer wall 46, the inflation/deflationlumen 40, an inner wall 48, the suction lumen 42, and the guidewire 44.

The inner wall 48 and the outer wall 46 may be made from any relativelyflexible material. When used in medical applications it is desirable,however, that the chosen material be approved for use in medicaldevices, be compatible with standard sterilization procedures, and beable to withstand the balloon's 36 inflation pressure without undueexpansion in the radial direction. One suitable material is nylon.However, other wall materials are within the scope of this invention. Insome embodiments, the inner wall 48 and the outer wall 46 comprise thesame material. These embodiments may be desirable because they aregenerally easier to manufacture. However, embodiments where the innerwall 48 is made from a different material than the outer wall 46 arewithin the scope of this invention. In addition, the inner wall 48 maybe reinforced in some embodiments with a metallic or plastic stent,strut, coil, or similar member, either in sections or for the fullextent. These reinforcement members may also be embedded into thecatheter wall.

The relative sizes and positions of the outer wall 46, theinflation/deflation lumen 40, the inner wall 48, the suction lumen 42,and the guidewire 44 are arbitrary. However, it is desirable to make theinflation/deflation lumen 40 and the suction lumen 42 as large aspossible so that they can provide greater suction to the distal end 24,and ease of inflation and deflation of the angioplasty balloon (whenthat is the operative member). That is, the maximum vacuum that may beapplied through the suction port 30 is limited by the wall materials.This maximum available vacuum is reduced by frictional losses betweenthe proximal end 22 and the distal end 24. Because frictional loses in aclosed channel are inversely proportional to the channel's crosssectional area, increasing the cross sectional area will increase thevacuum available at the distal end 24.

One method of increasing the cross sectional areas of theinflation/deflation lumen 40 and the suction lumen 42 is to make theouter wall 46, the inflation/deflation lumen 40, the inner wall 48, thesuction lumen 42, and the guidewire 44 substantially coaxial. Coaxialarrangements can increase the available cross sectional area because,for a circle

$\frac{A}{r} = {2\pi \; {r.}}$

Thus, a lumen located near the outside of the catheter 26 will have alarger flow area than will a lumen that is located near the interior ofthe catheter 26, even if both lumens consume the same amount of distancebetween the walls. It was discovered that the increased flow arearesulting from the coaxial arrangement can overcome its increasedsurface area.

Embodiments with coaxial lumens may be particularly desirable if theinner wall 48 helps to form both the inflation/deflation lumen 40 andthe suction lumen 42. These embodiments are desirable because thecatheter 26 only needs one internal structure to define two lumens.Despite these advantages, however, catheters having two or more innerwalls are also within the scope of the present invention. Theseembodiments may be desirable because they can define additional lumensand can allow one suction lumen 42 to physically move relative to theother inflation/deflation lumen 40.

Accordingly, in one five French catheter 26 embodiment having thecoaxial configuration shown in FIG. 4, the outer wall 46 has an outerdiameter of 0.066 inches and an inner diameter of 0.056 inches; theinner wall 48 has an outer diameter of 0.0455 inches and an innerdiameter of 0.0355 inches; and the guidewire 44 has an outer diameter of0.012 inches. This provides a suction lumen 42 with a cross sectionalarea of about 0.0008 square inches. This embodiment is particularlydesirable for use in carotid arteries procedures because it providessufficient suction to remove the obstruction before complications occurand because it is small enough to fit within the artery. Smallerdiameter catheters 26 (for example, between two and five French) havingsmaller suction lumens 42 may be suitable for use in less vital organs,where occlusion time limits are less critical, and in shorter catheters,where frictional losses are less significant. Larger diameter catheters26 (for example, between five and forty French) having larger suctionlumens 42 may be desirable for use in larger arteries, such as the aortaor iliacs, to accommodate the larger blood flow rate, and in longercatheters.

FIGS. 5 and 28 are more detailed views of the distal end 24 of theembodiment in FIG. 2. FIGS. 5 and 28 show that the inflation/deflationlumen 40 (see also FIG. 4) terminates in an opening 66 located insidethe balloon 36. This opening 66 allows air, saline solution, or someother inflation medium, to fill the balloon 36 and to bias it radiallyoutward against the obstruction. Similarly, the suction lumen 42 (seealso FIG. 4) terminates at a single opening 68 and/or a plurality ofpores 69 that are spaced along its length and around its perimeter.These openings 68 and/or pores 69 are used to remove smaller particlesfrom the treatment site and to suck larger particles into the trap 38.Embodiments in which the inflation/deflation lumen 40 terminatesimmediately at the proximal end of the balloon 36 may be particularlydesirable because this minimizes the profile of the balloon 36 in itscontracted configuration.

FIGS. 5 and 28 also show that the trap 38 in this embodiment comprises aplurality of flexible struts 49 in an arcuately expanded position. Inone embodiment, these struts 49 are fixedly attached to the guidewire 44by an inner stainless steel ring 50 and outer stainless steel ring 52,and to the exterior surface of the interior wall 48 by a stainless steelring 54. A flexible membrane 56 having an open end 58 and a closed end60 is attached to a distal portion of the struts 49. FIG. 29 shows analternate embodiment in which the branched housing 28 in FIGS. 5 and 28has been eliminated, with the guidewire going through an O-ring seal 130in the catheter's proximal end and an integral suction port in directfluid communication with the suction lumen.

The plurality of flexible struts 49 and the flexible membrane 56 combineto form the trap 38. In some embodiments, flexible struts 49 are longerthan the distance between the rings 50, 52 and the ring 54. This causesthe flexible struts 49 to function like a single-leaf semi-elliptic beamspring when in their arcuately expanded position.

The open end 58 of the flexible membrane 56 is attached to the flexiblestrut 49 near the area of maximum axial extension. However, the membrane56 could also be attached proximally or distally to the maximumextension point. The closed end 60 of the flexible membrane 56 isattached to one of the rings 50 and 52. The flexible struts 49 arepreferably radially spaced around the catheter 26 so that they canevenly bias the membrane 56 radially outward into contact with aninterior wall of a vessel or vessel-like structure.

In other embodiments, the struts 49 circle the guidewire or catheter andform a spiral configuration when in the expanded position, as shown inFIG. 7C. Flexible spiral struts 49 may be formed so that thesteady-state position is the spiral-shaped position of the trap. Inthese embodiments, the steady-state expanded position of the struts 49forms a side profile that may be either symmetrically shaped orasymmetrically shaped. In one embodiment, the profile 560, shown in FIG.7C is asymmetrical with a first end 561 having a larger radius ofcurvature 564 than a second end 562 with a smaller radius of curvature565. In one embodiment, the larger radius of curvature is 0.625 incheswhile the smaller radius of curvature is 0.250 inches. In thisembodiment, the ratio of larger radius of curvature to smaller radius ofcurvature is 2.5:1. Other embodiments may have different radii ofcurvature and different ratios. In a symmetrical profile the radii ofcurvature are equal.

In the embodiment depicted in FIG. 7C, the flexible membrane 56 isattached to the distal end of the trap 38 and to the guidewire 44 by adistal connection, which in this embodiment is rings 50, 52. Theflexible membrane 56 has an opening 58 at the area of maximum radialextension of the spiral-shaped strut 49. The opening allows the membraneto collect particles.

In the embodiment shown in FIG. 7C, rings 50 and 52 fixedly attach thedistal end of the flexible struts 49 to the guidewire 44. In anotherembodiment, only one ring is used to fixedly attach the distal end ofthe flexible struts 49 to the guidewire 44. Similarly, ring 54 fixedlyattaches the proximal end of the flexible struts 49 to the exteriorsurface of the catheter's inner wall 48.

Rotating the guidewire 44 relative to the catheter 48 will cause thestruts 49 to move between the helically twisted (or “braided”) positionshown in FIG. 7A and the arcuately expanded position shown in FIG. 7B.Rotating the guidewire 44 causes the distal end of the struts 49 torotate relative to the proximal end. This, in turn, forces the struts 49to wrap around the inner wall 48 of the catheter 26. Continued rotationof the guidewire 44 will continue to draw the struts radially inwarduntil they lie adjacent to the inner wall 48 of the catheter 26.

In embodiments with spiral shaped struts, shown in FIG. 7C, the expandedposition comprises struts 49 that circle around a central longitudinalaxis 561 of the device to form a spiral shaped configuration. Rotatingthe guidewire 44 relative to the inner wall 48 of the catheter 26 willcause the struts 49 to move between a helically twisted (or “braided”)position shown in FIG. 7A and a helically expanded position shown inFIG. 7C wherein the expanded struts form a spiral configuration. Tocontract the trap 38 following deployment, the guidewire 44 is movedrelative to the inner wall 48 of the catheter 26 to actuate the trap 38.

In some embodiments, the struts 49 have generally uniform physicalcharacteristics, such that when a torsional force is applied to thestruts, the mid-section of the trap 38 tends to close down around thecatheter 26, forming a waist 43 in the contracted trap 38. The waist 43creates a pinch-point to further trap particles. When the trap is closedby applying both a rotational motion and a longitudinal motion, theformation of the waist 43 will not occur so long as sufficientlongitudinal extension of the trap 38 is effected. In one embodiment,the further facilitate formation of the waist 43, the mid-section of thestruts 49 is formed to have less resistance to closure, using one of thetechniques outlined herein.

In some embodiment, FIG. 7F a first end of the trap 38 is constructed tobe less resistant to closure than the second end of the trap 38, so thatwhen the trap 38 is contracted, the first end will close first. When thefirst section closes first, that portion 601 of the struts tightlycontracts towards the guidewire 44 while for the second section, thatportion 603 has a tendency to not completely contract. The profile ofthe contracted trap 38 forms a cocoon 45 structure with one end having abulge 603 that gradually tapers to be tight against the guidewire 44.This embodiment enhances trapping capabilities because the bulge 603creates a pocket to hold particles that were not removed by suction.Having the bulge 603 is desirable because this section is not squeezed,and squeezing may cause particles to be pushed out of the membrane. Alsothis embodiment enhances trapping capabilities because the section 601tight against the guidewire creates a pinch so that particles remainwithin the trap until the device 20 is removed from the lumen.

FIG. 7G also depicts a cocoon structure 45 with a bulge 603 thatgradually tapers to be tight against the guidewire 44. This embodimentcorresponds to FIG. 7C with the flexible membrane 56 located at thedistal portion of the trap 38. The bulge 603 comprises the flexiblemembrane 56 in the contracted position. The tapered portion 601 of thecontracted trap comprises the opening 58 of the flexible membrane 56.The tapered portion 601 lies tightly against the guidewire 44 to trapparticles within the flexible membrane 56. The bulge 603 preventsparticles from being squeezed from the flexible membrane 56 duringcontraction of the trap 38.

To construct one end of the trap 38 as less resistant than another end,in one embodiment where the profile 560 of the trap 38 is asymmetrical,the end of the trap 38 with the largest radius of curvature will closefirst when rotated to the contracted position because it requires moreforce to close the end with the smaller radius of curvature. Therefore,as depicted in FIG. 7D, the larger radius of curvature 564 for the firstend 561 will cause the first end 561 to close first when the trap iscontracted. The second end 562 with the smaller radius of curvature 565will close after the first end 561 begins to close.

In one embodiment, the cocoon 45 is formed during contraction of thetrap 38 because a portion of the struts 49 between the membrane 56 andthe proximally-located ring 54 is thinner than a portion of the struts49 beneath the membrane 56. The thinner struts require less force tocontract and therefore close first. In another embodiment, the cocoon 43is formed because the portion of the struts 49 between the membrane 56and the proximally-located ring 54 is more resilient than the portion ofstruts 49 beneath the membrane 56. In this embodiment, a more resilientstrut 49 may be made from a different material having a differentelasticity. The end of the trap 38 having the larger radius ofcurvature, the thinner struts, or the more resilient material will closefirst. In another embodiment, a first portion of the struts 49 isconstructed with a cross-section having a first moment of inertia and asecond portion of the struts 49 is constructed with a cross sectionhaving a second moment of inertia. In this embodiment, the section withthe smaller moment of inertia will close first. In one embodimentaccording to the present invention, the membrane 56 covers the portionof the struts 49 having the greater resistance to closing. In oneembodiment, the membrane 56 covers the portion of the struts 49 havingthe greater resistance to closing and partially covers the portion ofthe struts 49 having less resistance to closing to enhance the abilityof the membrane 56 to trap embolic particles.

A membrane 56 may also be attached to the struts 49. The struts 49 maybe evenly spaced from one another to create maximum support for themembrane 56 forming the trap 38. The spiral configuration may enhancemaneuverability within the vessel, because the gaps between the struts49 allow for partial side-to-side and up-and-down movement withoutbuckling the strut 49. Accordingly, the spiral struts 49 are adapted tobe expanded in a curved portion of a lumen.

In one embodiment, the guidewire 44 is rotated and longitudinallyextended to cause rotation and translation of the distal section of thetrap 38 to prevent the membrane 56 from collapsing on itself in thecontracted position.

Rotating the guidewire 44 in the opposite direction will cause thestruts 49 to untwist, which allows the struts 49 to move back to thearcuately expanded position shown in FIG. 7B. This, in turn, expands thetrap 38. In other embodiments, rotating the guidewire 44 in the oppositedirection will cause the struts 49 to return to its expanded positionwhich allows the struts 49 to form the spiral configuration shown inFIG. 7C, expanding the trap 38.

To actuate the trap 38 using rotational or longitudinal or bothmovements, some embodiments of the present invention are equipped with ahandle 320 as depicted in FIG. 32. The handle 320 comprises a main body324 and cover 325, a screw configuration 330, and in some embodiment alocking device 340.

In one embodiment, the main body 324 and cover 325 comprise a generallycylindrical shape to comfortably fit the user's hand during theprocedure and are hollow to house the screw configuration 330 andlocking device 340. In addition, the cover 325 comprises openings 326where a thumbwheel 333 and a slide lock 341 are accessible to the userto operate the device.

The screw configuration 330 provides the rotational or longitudinal orboth types of movement to actuate the trap 38. The screw configuration330 comprises a luer 322, a ferrule 331, a thumbwheel 333, a drive screw335, and a stationary insert 337. The luer 322 is located at the distalend of the main body 324. The luer 322 is located external to the mainbody 324 with a cylindrical portion 323 entering into the main body 324.The luer 322 is a generally cylindrical device which provides aconnection device 346 to connect the inner catheter 48 to the handle 320and hold it stationary. The connection device 346 may be a threadedsection to mate with a threaded section of the inner catheter. The luer322 comprises an inner opening 321 for the guide wire 44 to enterthrough to connect to the thumbwheel 333.

The ferrule 331 provides a stop for the screw configuration. The ferrule331 is a generally cylindrical device with an inner opening 339 for anextension 332 of the thumbwheel 333 to enter through to connect to theguidewire 44. The ferrule 331 is slidable along the thumbwheel extension332. The ferrule 331 is provided so the screw configuration 330 will notdeploy the trap 38 beyond a predetermined maximum extension point.

The thumbwheel 333 is a generally cylindrically shaped device and isrotatable and controlled by the user. The thumbwheel extension 332 is arigid extension of the thumbwheel 333 and protrudes from the distal endof the thumbwheel 333. The guidewire 44 is rigidly connected to thethumbwheel extension 332 so that rotation of the thumbwheel 333 causesthe guidewire 44 to rotate relative to the stationary outer catheter148, 46. Rotation of the guidewire 44 relative to the stationary innercatheter 48 actuates the trap 38. The thumbwheel 333 comprises openings334 in which a connection device is used to rigidly connect thethumbwheel 333 to the drive screw 335.

The drive screw 335 is used to provide longitudinal movement to actuatethe trap 38. The drive screw 335 comprises a threaded surface 343 and ahead portion 344 with notches 336 for locking with a slidelock 341. Thenotches 336 may be in the form of a linear protrusion on the surface ofthe head portion 344 which would match with an indented portion on theslidelock 341.

The stationary insert 337 is rigidly connected to the main body 324 ofthe handle 320. The stationary insert 337 contains an opening 338through which a drive screw 335 enters. The opening 338 comprises athreaded surface to mate with the threaded surface 343 of the drivescrew 335. Because the stationary insert 337 is rigidly connected to themain body 324, but the drive screw 335 is freely movable, rotation ofthe thumbwheel 333, which is rigidly connected to the drive screw 335,causes longitudinal, rotational or both types of movement of the drivescrew 335, thumbwheel 333 and therefore the guidewire 44.

In embodiments with the handle and screw configuration, the longitudinalmovement generated by the drive screw 335 is transferred to theguidewire 44. When the trap 38 is expanded, the guidewire 44 rotates andalso longitudinally decreases the distance between the connection rings50,52 and 54. When the trap 38 is contracted, the guidewire 44 rotatesand also longitudinally increases the distance between the connectionrings 50, 52 and 54. The ratio of longitudinal motion to rotationalmotion is controlled by altering the pitch of the drive screw 335.

The locking mechanism 340 comprises a slidelock 341 which slidablyengages with the screw head 344 to lock the screw 335 from furthermovement. The locking mechanism 340 comprises an internal locking wheel342 with indented portions 346 to engage with the protrusions 336 on thedrive screw head 344. The slidelock 341 is slidably connected to themain body 324 so that only linear movement of the slidelock 341 isallowed. Therefore, when the slidelock 341 is shifted in the distaldirection to engage with the screw head protrusions 336, the drive screw335 is also prevented from rotational movement. Because the drive screw335 is rigidly connected to the thumbwheel, which is in turn is rigidlyconnected to the guidewire 44 or inner catheter 48, 302, none of thesecomponents are allowed to move either, thus locking the trap 38.

The threaded sections 343 of the drive screw 335 comprises a pitch sothat with each rotation, the drive screw moves in a longitudinaldirection. The longitudinal movement along with the rotational movementis transferred to the distal end of the trap 60. The rotational movementactuates the trap to the expanded or contracted position. Thelongitudinal movement causes the guidewire 44 to move in a longitudinaldirection. The distance between the strut attachment points 50, 52 and54 is increased when the trap is contracted. This increased distancehelps prevent the trap 38 from collapsing and bunching over itself inthe contracted position.

In one embodiment, the guidewire 44 is a catheter or any other movablemember. In this embodiment, the distal end of the struts 49 would beattached to the inner catheter and form the movable member while theproximal end of the struts would attach to the outer catheter and formthe stationary member. A slideable guidewire may then pass through theinner catheter. It is understood that in one embodiment to actuate thetrap one end of the trap is connected to the movable member while theother end of the trap is connected to the stationary member. The handlemay be used to actuate the trap with any combination of guidewires andcatheters, so long as the function of actuating the trap isaccomplished.

FIG. 8 is a sectional view of the angioplasty device 20 in FIG. 5 takenalong the line BB. This figure shows four optional stiffening members 70that connect the inner wall 48 to the outer wall 46. These stiffeningmembers 70 define a plurality of openings 72 that keep theinflation/deflation lumen 40 (see FIG. 4) fluidly connected to theballoon 36 (see FIGS. 5 and 28). These stiffening members 70 aredesirable because they give the user something to “push against” whenactuating the trap 38. That is, a user expands and contracts the trap 38(see FIGS. 5 and 28) by rotating the guidewire 44 around itslongitudinal axis. The torque used to rotate the guidewire 44 istransferred to the inner wall 48 through the struts 49, which causes theinner wall 48 to twist. The stiffening members 70 couple the inner wall48 and the outer wall 46. The combined torsional stiffness (or perhapsmore accurately, the combined polar moment of inertia) of the inner wall48 and the outer wall 46 is greater than that of the inner wall 48alone. In this embodiment, the stiffening members 70 may extendthroughout the length of the catheter 26 or may only extend a shortdistance from the opening 66.

FIGS. 9A and 9B are side plan and sectional views of an angioplastydevice 20 having a screw extension system 80 located near the distal endof the suction lumen 42. However, screw extension systems 80 located inother locations, such as within the housing 28, are also within thescope of the present invention. The screw extension system 80 in thisembodiment comprises a helical screw thread 82 attached to the guidewire44 and a pair of offset studs 84 attached to the inner wall 48. Theoffset studs 84 engage the helical screw thread 82 without blocking thesuction lumen 42, which causes the guidewire 44 to move axially insidethe suction lumen 42 when rotated. Embodiments having this screwextension system 80 are desirable because it increases the distancebetween the distal rings 50 and 52 and the proximal ring 54 (see FIGS. 5and 28), which helps the struts 49 to contract into an orientation thatis smooth and tight against the guidewire 44.

FIG. 10 shows a flexible membrane extension system 80 a that may be usedin place of or in conjunction with the screw extension system 80 ofFIGS. 9A and 9B. FIG. 10 depicts the proximal end of the guidewire port34, which comprises a generally cylindrical housing 86 and a generallycylindrical lumen 87 that is fluidly connected to the suction lumen 42(see FIG. 4). The guidewire 44 runs through the lumen 87 and isconnected to a disk shaped handle 88. FIG. 10 also depicts a flexiblemembrane 89 that is attached to the housing 86 and to the handle 88.

As described with reference to FIGS. 7A, 7B, 7C, 7E and 7F, the userexpands and contracts the trap 38 by rotating the guidewire 44 aroundaxis ZZ (see FIG. 10). The guidewire 44, in turn, may be rotated bymanually turning the handle 88. Because the membrane 89 is fixed to boththe housing 86 and the handle 88, however, this rotation causes themembrane 89 to twist. This twisting motion causes the membrane 89 tobunch together, which pulls the handle 88 in a distal direction towardsthe housing 86. The handle 88, in turn, pushes the guidewire 44 throughthe catheter 26.

Embodiments using the flexible membrane extension system 80 a in FIG. 10are desirable because the membrane 89 longitudinally biases the proximalring 54 relative to the distal rings 50 and 52, thereby helping toactuate the trap 38, and because the membrane 89 helps to seal thesuction lumen 42. Preferably, the membrane 89 will comprise materialsand dimensions such that the amount of rotation necessary to actuate thetrap will also produce the desired longitudinal motion. Other extensionsystems 80, such as a spring or other elastic member located between thehandle 88 and the housing 86, and other sealing systems, such as amembrane 89 that completely surrounds the handle 88, an O-ring, or awiper style seal, are also within the scope of the present invention.

Referring again to FIGS. 5 and 28, the struts 49 may be made from anyelastic material. It is desirable, however, that the material beapproved for use in medical devices when used in medical applications,have a relatively high modulus of elasticity, and have a relatively goodresilience. One particularly desirable class of materials are “shapememory alloys,” such as Nitinol®. These materials are desirable becausethey can be easily “taught” a shape to which they will return afterhaving been deformed. Manufacturers can use this feature to form struts49 that will naturally return to their arcuately expanded position whena user releases the guidewire 44. Despite these advantages, however,other strut materials are within the scope of the present invention.This specifically includes, without being limited to, stainless steeland polymers.

A method for making the trap and forming the struts 49 in the spiralconfiguration as shown in FIG. 7C may be used using a profile device.FIG. 31 depicts one embodiment of a profile device 400. The method formaking the spiral shaped strut may comprise using a “shape memory alloy”to form the desired steady-state spiral struts 49 in the expandedposition. This method involves positioning the struts 49 parallel to thelongitudinal axis Z-Z of the device over a profile device 400 with adesired profile 402, i.e., egg shape, oval shape. The device 400 fixedlyholds the struts 49 at a first 408 and second 406 end with a clampingdevice for fixing the strut. In addition, the device 400 across thecenter portion may have gaps 410 for the struts to be rigidly placed in.The gaps 410 keep the struts 49 evenly spaced from one another duringthe method of making the trap. The device 400 may include a rotatablesection 404 and a stationary section 405. To form the spiral shapedstruts 49, a rotatable portion 404, 406 of the device is rotatedrelative to a stationary portion 405, 408. The rotatable portion 404,406 device is rotated in one embodiment 90° to achieve a spiralconfiguration. In another embodiment, both the stationary portion 405,408 and the rotatable portion are rotated in opposite directions toachieve a spiral configuration. Other rotation degrees are within thescope of the present invention.

The strut are made of a material that may be set in the expandedposition so that the steady-state position of the struts 49 is theexpanded position of the profile device. In some embodiments the profiledevice is rotated and then the metal is set so that the expandedposition of the struts forms a spiral configuration. In one embodimentthe method used to set the strut material is heat treatment that wouldset the shape memory alloy of the struts 49 in the shape of the profile.In one embodiment the heat treatment is performed at a temperature of500° F. for 10 minutes. In another embodiment, a sand bath with heatedsand at 500° F. is applied for 5 minutes. Other times and temperaturesare within the scope of the invention along with other methods ofapplying heat and in addition other methods of setting the material,like using electricity.

After the struts 49 are set, then the struts may be used in making thetrapping device of the angioplasty device. Various numbers of struts maybe used along with different profile shapes and different rotations ofthe rotatable portion 404.

Another method for making the trap and forming the struts is to firstform the struts not as individual sections of metal, but form the strutsby 20 cutting parallel sections from a tube. FIGS. 33A-33E depicts atube 500 and the tube 500 with cut sections 501 forming struts 503. Inthis embodiment the midsection of the tube 500 is cut while leaving theends 502, 505 of the tube intact. In this embodiment the material of thetube 500 can also be a shape memory alloy that may be set using heattreatment or other setting methods. In another embodiment, as shown inFIGS. 34A-34C, teardrop-shaped or wedge-shaped cut-outs 507 are formedin the tube 500, and this portion of the tube 500 is removed as shown.With these cut-outs 507 removed, the sections remaining form the struts503 with a first end 508 thinner in width than a second end 509.

To form the profile shape, a profile device 510 is placed within theopening of the struts. This profile device 510 may have the shape of adesired profile 511, in one embodiment an egg shape. The profile device510 has an opening 512 longitudinally through it. The profile device 510is inserted into the cut sections 501, 507 of the tube 500. A generallyrigid device is placed through the opening 512 of the profile device 510so that a generally linear shape of the trap is formed. With the profiledevice 510 in position, the ends of the tube 502, 505 are clamped andthen the struts 503 are set. In some embodiments one clamped end 505 isrotated relative to a stationary end 502 to form a spiral configuration506 of the struts 503 and then the struts 503 are set. In oneembodiment, the struts are set using heat treatment of 500° F. for 10minutes or in a heated sand bath at 500° F. for 5 minutes. Other methodsof setting the material, as known in the art, are within the scope ofthe invention.

In the embodiment depicted in FIGS. 34A-34C, the variable width of thestruts 503 in the longitudinal direction helps facilitate control ofclosing one end of the trap before the other end of the trap. The firstend 508 of the trap, having the narrower portion of the struts, requiresless force to close, and therefore that end will close before the endhaving the wider portion of the struts.

In one embodiment, using the device shown in either FIGS. 33A-33E orFIGS. 34A-34C, a trap is formed by attaching a membrane (not shown) overa portion of the struts 503, and the trap is actuated using a guidewireor other movable member inserted through the lumen of the tube 500 andcoupled to the distal end 505. To actuate the trap, the movable memberis then rotated, translated longitudinally, or both, which causes thestruts 503 to close beginning with the first end 508.

The guidewire 44 may be any device capable of guiding the catheter 26into the treatment site and capable of transmitting sufficient torquefrom the guidewire port 34 to the struts 49. The guidewire 44 in someembodiments is made from a braided stainless steel wire. Theseembodiments are desirable because stainless steel has excellent strengthand corrosion resistance, and is approved for use in medical devices.Stainless steel's strength and corrosion resistance may be particularlydesirable for use in catheters having diameters of five French or less.Despite these advantages, non-braided guidewires 44; guidewires 44 madefrom other materials, such as platinum or a polymer; and embodimentshaving a removable guidewire 44 are within the scope of the presentinvention. The removable guidewire 44 in these embodiments may beoperably connected to the struts 49 by any suitable means, such asmechanical or magnetic linkages.

The guidewire 44 in some embodiments may taper along its length from alarger diameter at the branching housing 28 to a smaller diameter at thetrap 38. These embodiments are desirable because they help prevent theguidewire 44 and the catheter 26 from “looping” around themselves duringuse. Looping is commonly observed in phone cords and occurs when a wireis twisted around its longitudinal axis. Despite this advantage,non-tapered guidewires 44 are also within the scope of the presentinvention.

In some embodiments, as best shown in FIG. 6, the struts 49 are clampedto the guidewire 44 by the rings 50 and 52. In these embodiments, theinner ring 50 is first attached to the guidewire 44 by any suitablemechanical means, such as swedging, press fitting, or brazing. Thestruts 49 are then aligned over the inner ring 50 and locked into placeby swedging, press fitting, brazing, or other suitable means the outerring 52 over and around the struts 49. In some embodiments, the struts49 are coated with a material, such as textured polyurethane, that helpsto prevent the struts 49 from slipping out of the rings 50 and 52 andthat helps to adhesively connect the struts 49 to the membrane 56. Ring54 similarly clamps the proximal end of the struts 49 against the innerwall 48 of the catheter 26. The single ring 54 may be attached to thestruts 49 by any suitable means, such as swedging, press fitting, orthrough use of adhesives.

The struts 49 may also be embedded into the inner wall 48 of thecatheter 26 or may be inserted into longitudinal grooves formed into theinner wall 48 in some embodiments, or alternatively, the catheter 26 maybe formed or over-molded around the struts 49. These features may bedesirable for small diameter angioplasty devices 20 because they mayreduce the diameter of the ring 54 and because they may help to lock thestruts 49 inside the ring 54. Inserting or embedding the struts 49 intothe wall of the catheter can also eliminate the need for the ring 54.

Although stainless steel rings 50, 52, 54 are desirable to attach aNitinol® strut 49 to a stainless steel guidewire 44, those skilled inthe art will recognize that other means of attaching the struts 49 arewithin the scope of the present invention. This specifically includes,without being limited to, rings 50, 52, 54 made from other materials,such as mylar, that can be bonded to the coating on the struts 49 andthe use of welding and/or adhesives to directly bond the struts 49 tothe guidewire 44 and/or the inner wall 48. These alternative methods maybe particularly desirable when used with struts 49 that are made frommaterials other than Nitinol® and when the guidewire 44 is made frommaterials other than stainless steel. These alternate attachment meansmay also be desirable for use with the embodiments shown in FIGS. 14-30.

The number of struts 49 and their dimensions are arbitrary. However,more struts 49 are generally desirable because they can more accuratelybias the membrane 56 against the vessel or vessel-like structure. It isalso desirable that each strut 49 have dimensions large enough that theycan bias the membrane 56 against the vessel with sufficient force toprevent physiologically significant particles from escaping around thetrap 38, but not so large that the struts 49 will prevent capture of theparticles or so large that the struts 49 will interfere with each otherwhen in their closed position. One suitable five French catheter 26embodiment uses eight 0.006 inch×0.003 inch Nitinol® struts.

The membrane 56 may be any material capable of stopping physiologicallysignificant materials from leaving the treatment site when the trap 38is expanded. In some embodiments, the membrane 56 is made from arelatively strong, non-elastic material. Non-elastic materials aredesirable because they do not counteract the radially outward biasingforce developed by the struts 49. In other embodiments, the membrane 56is made from an elastic or semi-elastic material, such as polyurethane,polyester, polyvinyl chloride, or polystyrene. These embodiments aredesirable because the elasticity may help the struts 49 to close thetrap 38. In still other embodiments, the membrane 56 is porous. Theseembodiments may be desirable because the pressure developed by patient'sheart will help deliver particles into the trap 38.

FIG. 11A shows an angioplasty device 20 capable of providing suctiondistal to the angioplasty device 20 while it is being inserted into thetreatment site. In this embodiment, the ring 50 is replaced with a disk92 attached to the inner wall 48 and a disk 94 attached to the guidewire44. These two disks 92 and 94 act as a valve capable of selectivelypermitting suction to that portion 99 of the vessel immediately in frontof the angioplasty device 20. That is, as shown in FIGS. 11B and 11C,each disk 92 and 94 has two open portions 96 and two blocking portions98. Rotation of the guidewire 44 causes disk 94 to rotate relative todisk 92. This relative motion causes the disks 92 and 94 to alternatebetween an “open” orientation in which the openings 96 in disk 92 arealigned with the openings 96 in disk 94 and a “closed” orientation inwhich the openings 96 in disk 92 are aligned with the blocking portions98 in disk 94. Preferably, the same rotation of the guidewire 44 used totoggle the disks 92 and 94 between their open and closed orientationsalso expands and contracts the trap 38.

In operation, the user would first rotate the guidewire 44 until thedisks 92 and 94 are in the open orientation. In this orientation, theopenings 96 cooperate to create a fluid communication channel betweenthe suction lumen 42 and that portion 99 of the vessel immediatelydistal to the angioplasty device 20. This allows the user to providesuction in front of the angioplasty device 20 while the user inserts itinto the vessel. Once the angioplasty device 20 is in place, the userwill rotate the guidewire 44 until the disks are in the closedorientation. In this orientation, the blocking portions 98 cooperate toprevent fluid from flowing through the disks 92 and 94. This, in turn,creates suction inside the trap 38.

FIGS. 12A and 12B show an angioplasty device 20 with an alternate valveembodiment 120. This valve embodiment 120 comprises a disk shapedabutment 121 that is rigidly attached to the catheter wall 48 and astopper 122 that is rigidly attached to the guidewire 44 at a locationdistal to the abutment 121. The stopper 122 has a conically shapedsurface 124 on its distal end and a generally planar engagement surface126 on its proximal end. The engagement surface 126 of the stopper 122can selectively plug a circular flow channel 128 that is coaxiallylocated in the abutment 121. The valve 120 allows the user to applysuction to the portion 99 of the vessel immediately in front of theangioplasty device 20 through a hole 129 in the membrane 56.

In operation, the valve embodiment 120 is actuated by longitudinallymoving the guidewire 44 relative to the catheter wall 48. That is,pulling the guidewire 44 in a proximal direction relative to thecatheter wall 48 causes the generally planar engagement surface 126 tosealably engage the abutment 121, which prevents fluid from flowingthrough the circular flow channel 128. Pushing the guidewire 44 in adistal direction relative to the catheter wall 48 causes the stopper 122to disengage from the abutment 121, which allows fluid to flow throughthe circular flow channel 128.

Other valve embodiments 120 capable of being actuated by longitudinalmotion are also within the scope of the present invention. For example,the stopper 122 may be rotated 180 degrees so that the conically shapedsurface 124 engages the abutment 121, rather than the generally planarengagement surface 126. These embodiments may be desirable because theconically shaped surface 124 will self-center the stopper 122 in theflow channel 128. Also, the stopper 122 may be located proximal to theabutment 121. In addition, the stopper 122 may have other shapes, suchas a sphere or a cylinder.

Those skilled in the art will recognize that the valve 120 and the disks92, 94 can be eliminated in these embodiments, which allows the suctionlumen 42 to simultaneously provide suction under the trap 38 and distalto the angioplasty device.

FIG. 13 shows an embodiment where the balloon 36 and the trap 38 areassociated with separate catheter bundles. That is, FIG. 13 shows anembodiment of the present invention comprising a trap catheter bundle100 for the trap 38 and a balloon catheter bundle 102 for the balloon.In operation, the trap catheter bundle 100 is inserted into vessel untilthe trap 38 is situated distal to the obstruction site. The ballooncatheter bundle 102 is then loaded over the trap catheter bundle 100 andused to remove the obstruction. This balloon catheter bundle 102 shouldhave a centrally located lumen 104 having an interior diameter largerthan the trap catheter bundle 100. Alternatively, the balloon catheterbundle 102 or other device (such as an angioscope) may be delivered tothe treatment area through a lumen 150 and an opening 152 in the trapcatheter bundle 100 (see FIGS. 16-18).

FIGS. 14 and 15 are sectional views of two trap catheter bundleembodiments 100. Specifically, the trap catheter bundle 100 in FIG. 14is configured to be inserted in an antegrade direction (i.e., in samethe direction as the fluid flow) along a guidewire 44. Thus, the opening58 in its membrane 38 faces towards its proximal end. The opening 58 inFIG. 15, in contrast, faces the catheter's distal end because thiscatheter bundle 100 is configured to be inserted in a retrogradedirection (i.e., with insertion site “downstream” in relation to thedirection of fluid flow) along a guidewire 44. Both trap catheterbundles 100 may be sized and shaped so that they can be inserted throughthe guidewire channel of a balloon catheter bundle 102. Those skilled inthe art will recognize that the trap catheter bundle embodiments 100 inFIGS. 14 and 15 can also be used to capture embolic debris without aballoon catheter bundle 102 and to deliver diagnostic and therapeuticagents to a treatment area.

FIGS. 14 and 15 also show a seal 130 that may be used in place of or inaddition to the flexible membrane extension system 80 a depicted in FIG.10 to prevent air or other fluid from leaking into the suction lumen 42.Accordingly, the seal 130 may be any device, such as an elastomericO-ring or wiper, that prevents fluid from leaking through the guidewireport 34 and that allows the guidewire 44 to move relative to thecatheter wall 148. Embodiments using an O-ring or a wiper style seal 130are particularly desirable because the user can slide the guidewire 44longitudinally relative to the catheter bundle 102 to help actuate thetrap 38.

FIG. 15A is a sectional view of a trap catheter bundle embodiment with astepped-up suction lumen 42. In this embodiment there is an opening 68in fluid communication with the suction lumen along with suction pores69 in fluid communication with the suction lumen. The diameter of thesuction lumen 42 is smaller in the portion under the membrane 56 thananother portion leading to the suction port 30. The suction pores 69 arelocated on both portions of the suction lumen 42. It is understood thatthe stepped-up suction lumen may be the lumen that receives a guidewire44 or another catheter and that an inflation lumen may also be provided.

FIG. 15B is a sectional view of a trap catheter bundle embodiment withthe guidewire 44 having a solid portion 440 and a hollow portion 442providing the suction lumen 42 with pores 69. The guidewire 44 may belocated within an inflation lumen 40.

FIGS. 16 and 17 are sectional views of two trap catheter bundleembodiments 100 in which the trap is actuated by relative motion betweenthe inner catheter wall 48 and the outer catheter wall 46. That is, theuser actuates the trap 38 in this embodiment by rotating the innercatheter wall 48 relative to the outer catheter wall 46, rather thanrotating a fixed guidewire 44 relative to the inner catheter wall 48.These embodiments are desirable because they can be loaded over aseparate guidewire (not shown) or angioplasty device (not shown) thathas previously been inserted into the patient using lumen 150 andopening 152. In these embodiments, various forms of arcuately expandedpositions of struts may be utilized including but not limited toexpanded positions where the struts are parallel to the longitudinalaxis of the device or expanded positions where the struts form a spiralconfiguration and circle the longitudinal axis of the device. Theseembodiments are also desirable because inner catheter wall 48 can beslid longitudinally with respect to the outer catheter wall 46 to helpopen and close the trap 38. In an appropriately designed ballooncatheter bundle, these trap catheter bundles could be inserted throughthe lumen 150 of the angioplasty balloon catheter. Like the trapcatheter bundle embodiments 100 in FIGS. 14 and 15, the trap catheterembodiments 100 in FIGS. 16 and 17 can be inserted in either theantegrade or retrograde direction, and can be used with or without aseparate balloon catheter bundle 102. In one embodiment, the handle 320(shown in FIG. 32) is used to actuate movement of the inner catheterwall 48 and hold the outer catheter wall 46 stationary and similarlongitudinal and/or rotational movement through the handle 320 (shown inFIG. 32) may be used to actuate the trap 38 as discussed in otherembodiments.

FIG. 18A is a sectional view of an angioplasty device 20 embodiment foruse in retrograde applications (see FIG. 1 of U.S. Pat. No. 4,794,928for conceptional orientation, which is herein incorporated byreference). This embodiment comprises a separate catheter 160 for theballoon 36 and for the inflation/deflation lumen 40. This catheter 160has a first wall 162, a second wall 163, and an end wall or plug 164. Inoperation, the trap 38 in this embodiment is actuated by relativerotational and/or longitudinal motion between the exterior wall 46 andthe first wall 162 of the catheter 160. In one embodiment, the handle320 (shown in FIG. 32) provides the movement of first wall 162 relativeto exterior wall 46.

FIG. 18B is sectional view of an angioplasty device 20 embodimentconfigured for use in the antegrade direction and for use with apre-inserted guidewire. This angioplasty device 20 embodiment includesan inner wall 302, an intermediate wall 304, an outer wall 306, and anend seal 307. The inner wall 302 forms a guidewire receiving lumen 150having a shape and size suitable to slideably receive a guidewire 44.The inner wall 302 and the intermediate wall 304 form a suction lumen42, which is fluidly connected to a suction port 30 and a plurality ofopenings 68 and/or pores 69. The intermediate wall 304 and the outerwall 306 form an inflation/deflation lumen 40, which is fluidlyconnected to the balloon 36. In operation, the trap 38 is actuated usingrelative rotational and/or longitudinal motion between the intermediatewall 304 and the inner wall 302. In one embodiment, the handle 320(shown in FIG. 32) provides the relative movement between theintermediate wall 304 and the inner wall 302.

Like the embodiments in FIGS. 16-17, 19 and 27, the angioplasty deviceembodiments 20 in FIGS. 18A and 18B are desirable because they may beloaded over a separate guidewire (not shown in FIG. 18A) or catheter(not shown) that has previously been inserted into the patient. In atypical over-the-wire surgical procedure, a surgeon may first insert aguidewire 44 into a vessel-like structure using a long hypodermic needletube or other suitable device (not shown) until the guidewire 44 extendsto a desired point past the obstruction. The surgeon then inserts theangioplasty device 20 over the guidewire 44 until the trap 38 is locateddownstream from the obstruction. That is, the surgeon slides theangioplasty device 20 down the guidewire 44 (with the guidewire 44sliding through the guidewire lumen 150) to the treatment site. Afterthe angioplasty device 20 is properly positioned, the surgeon thenperforms the angioplasty procedure as previously described. Theseover-the-wire embodiments may be desirable for use in severely occludedvessels because the separate guidewire 44 is easier to manipulatethrough the obstruction and because many surgeons are experienced ininserting and manipulating the separate guidewire 44 into the properposition. Over-the-wire embodiments are also desirable because the lumen150 may be used to deliver medicine, blood, or other fluid past theobstruction during the procedure.

FIG. 19 is a sectional view of an angioplasty device embodiment having acoupling device 190 with four radially spaced sockets 189. FIG. 20 is asectional view of the coupling device 190. The coupling device 190 inthis embodiment may be any device that prevents the balloon catheter 102from rotating relative to the trap catheter bundle 100 (or translating,if used with the trap embodiment 38 described with reference to FIGS. 21and 22). These embodiments are desirable because the trap catheterbundle 100 and the balloon catheter bundle 102 may be manufacturedseparately, then combined as needed. FIG. 27 depicts an alternateembodiment in which a second group of struts 49 aconnect the couplingdevice 190 to an end 191 of the trap catheter bundle 100. In operation,the trap catheter bundles 100 in FIGS. 19 and 27 may be inserted over anin-place balloon catheter 102 and then either removed along with theballoon catheter 102 or by itself, depending on the configuration of thecoupling devices 190. The embodiments in FIGS. 19 and 27 may also beinserted over a guidewire 44 (not shown) or a may have a fixed guidewire44 extending distally from it.

FIGS. 21 and 22 are sectional views of another trap catheter bundleembodiment 100, in which the trap 38 is actuated by a translationbetween the guidewire 44 and the catheter wall 148. In this embodiment,a first end 180 of the struts 49 is connected to the guidewire 44 and asecond end 182 of the struts 49 is attached to the catheter wall 148.Translating the guidewire 44 (i.e., moving the guidewire in an axialdirection) relative to the catheter wall 148 biases the first end 180away from the end 182. This, in turn, actuates the struts 49 between anarcuately expanded position, such as that shown in FIG. 21, and acontracted position, such as that shown in FIG. 22. Accordingly, thestruts 49 in this embodiment remain generally parallel to the guidewire44 throughout the procedure. Those skilled in the art will recognizethat this actuation mechanism also could be used with the embodimentsdescribed with reference to FIGS. 1-20.

FIGS. 23A-24B are sectional views of two modular trap embodiments 200having an adaptive coupling device 202, and a permanent or detachableand/or insertable manifold 203. These embodiments are desirable becausethe user can add aspiration and blocking features to a conventionalangioplasty device 212, and because the user can customize the operativedevice and the trap for a particular operation. In FIG. 23A, thecoupling device 202 comprises a male snap ring 204 that is adhesivelybonded to a modular catheter wall 206 and a female snap ring 208 that isadhesively bonded to an outer wall 210 of a conventional angioplastydevice 212. The snap rings 204 and 208 sealably mate together, whichfluidly connects a modular catheter lumen 205 to the suction lumen 42.In FIG. 24A, the coupling device 202 comprises a first ring 220 and asecond ring 222. The first ring 220 has a circumferential slot 224 inits proximal end into which the struts 49 are fixed and acircumferential tab 226 that projects axially from its distal end. Thesecond ring 222, which is attached to a conventional angioplasty device212, has a circumferential slot 228 into which the tab 226 is press fit,snap fit, or otherwise locked shortly before use. Alternatively, secondring 222 could be eliminated and the tab 226 inserted directly into, andheld in place by, the suction lumen 42 and/or an adhesive or tape. Theembodiment in FIG. 24A may be particularly desirable because it does notrequire a modular catheter wall 206.

Alternately, as shown in FIGS. 23B and 24B, the snap ring 208 (or thesecond ring 222) could also be attached to the inner wall 48. Theseembodiments may be desirable because they provide a lower profileballoon catheter. FIGS. 23B and 24B also show that the snap ring 204 canhave a circumferential slot 293 in its proximal end into which thestruts 49 are fixed.

FIG. 30 shows a modular, antegrade angioplasty device 20 embodimentadapted for use in over-the-wire procedures. This angioplasty device 20embodiment includes a coupling device 202, an inner wall 302, anintermediate wall 304, an outer wall 306, an end seal 307, a guidewirereceiving lumen 150, a suction lumen 42, a suction port 30, a pluralityof openings 68 and/or pores 69, an inflation/deflation lumen 40, and aballoon 36. In operation, the trap/barrier 38 is actuated using relativerotational and/or longitudinal motion between the intermediate wall 304and the inner wall 302. In one embodiment, the handle 320 (shown in FIG.32) provides the movement to actuate the trap by moving the inner wall302 relative to intermediate wall 304. These embodiments are desirablebecause the trap/barrier 38 can be separately attached to theangioplasty balloon catheter component of the angioplasty device 20,which gives greater flexibility for using various sized trap/barriercomponents with a given angioplasty catheter, while retaining theadvantages of over-the-wire operation. The trap 38 in FIG. 30 may alsobe adapted to incorporate part of the suction lumen, as shown in FIG.23B.

FIGS. 25 and 26 are sectional views of two embodiments having a hollowguidewire 248. These embodiments are desirable because a lumen 250defined by the hollow guidewire 248 can be used as an alternate suctionlumen. The hollow guidewire 248 in these embodiments includes a singleopening 253 and/or a plurality of pores 254 that are radially andaxially spaced inside the struts 49. The pores 254 allow the alternatesuction lumen 250 to help the suction lumen 42 remove smaller particlesfrom the treatment site and suck larger particles into the trap 38. Theopening 253 allows the alternate suction lumen 250 to selectivelyprovide suction distal to the angioplasty device 20 while it is beinginserted into the treatment site and allows the alternate suction lumen250 to selectively deliver treatment and/or diagnostic agents. Thoseskilled in the art will recognize that the hollow guidewire 248 may alsobe used in the embodiments described with reference to FIGS. 2-24B and27-30 and that the housing 28 can be modified to include two or moresuction ports.

Referring again to FIG. 2, the guidewire port 34 can be any device thatallows for relative rotation of the guidewire 44 with respect to thecatheter 26. In some embodiments, this relative rotational and/orlongitudinal movement is provided by the handle 320 (shown in FIG. 32).In some embodiments, the guidewire port 34 may include an apparatus (notshown) that will indicate the relative position and/or torque of theguidewire with respect to the catheter 26. These embodiments may bedesirable because they can help ensure that the struts 49 are rotatedinto their fully expanded position. The guidewire port 34 may include anauxiliary apparatus (not shown) that maintains the guidewire 44 in aparticular orientation corresponding to the maximum expanded position.This apparatus may reduce the number of medical personnel necessary toperform the entire procedure.

The suction port 30 and the inflation port 32 may be any devices that,respectively, allow for operable connection to a vacuum source and apressure source. In some embodiments, the suction port 30 and theinflation port 32 comprise a polymeric tube that is adapted to receiveto a syringe. One syringe may contain the fluid to be injected throughthe inflation/deflation lumen 40 and into the balloon 36. Anothersyringe may suck fluid and particles from the trap 38 through thesuction lumen 42.

The present invention offers many advantages over the known angioplastydevices. For example, it provides a total capture angioplasty devicethat can be scaled into small diameter devices. Total captureangioplasty devices having dimensions of about five French and smallercan be easily achieved with the present invention. The present inventioncan also provide a fixed guidewire to aid insertion into irregularstenosis and a trap 38 that may be actively closed around particles thatare too large to be sucked through the suction lumen 42. In addition,the struts 49 can act as an additional trap during actuation. That is,as the trap 38 is contracted, the struts 49 prevent smaller and smallerparticles from escaping. In addition, the present invention is desirablebecause it maximizes the amount and rate of suction per unit size, andbecause it allows the user to perform multiple tasks using a singlecatheter device.

Although the present invention has been described in detail withreference to certain embodiments thereof, it may be embodied in otherspecific forms without departing from the essential spirit or attributesthereof. For example, lumens 42 and 150 could be used to introducemedicinal agents and radiopaque liquids, or to take samples of a fluidbefore, during, or on completion of a procedure. In these embodiments,the medicinal agent could be introduced into the catheter 26 through anappropriate port by suitable means, such as a syringe. These embodimentsmay be particularly desirable if combined with a porous membrane 56. Inaddition, the stainless steel guidewire 44 could be replaced by anoptical fiber. These embodiments may be desirable because they couldallow the surgeon to view the treatment site before and after theprocedure. Still other embodiments of the present invention may coat theguidewire 44 and the catheter 26 with a lubricant, such aspolytetrafluoroethylene (“PTFE”), to reduce friction.

Those skilled in the art will recognize that the term “angioplasty” asused throughout this specification and the claims was intended toinclude, without being limited to: (1) any of the medical and/orveterinary procedures and treatments described in the backgroundsection; (2) procedures and treatments similar to those described in thebackground section; and/or (3) any other treatment or procedureinvolving the removal of an obstruction from vessels or vessel-likestructures, regardless of whether such structures are part of orassociated with a living organism, and specifically including, withoutbeing limited to, the use of the present invention to removeobstructions from “non-living” tubes, tubules, conduits, fibers or otherstructures in non-medical or industrial applications. Thus, the presentinvention could, for example, be used to remove an obstruction from afluid delivery tube within a machine under conditions where it would beundesirable for particles of the obstruction to break free and continuedown the tube, e.g., if the machine were still running and particleswould jeopardize continued operation.

Those skilled in the art will also recognize that the accompanyingfigures and this description depicted and described embodiments of thepresent invention, and features and components thereof. With regard tomeans for fastening, mounting, attaching or connecting the components ofthe present invention to form the mechanism as a whole, unlessspecifically described otherwise, such means were intended to encompassconventional fasteners such as machine screws, nut and bolt connectors,machine threaded connectors, snap rings, screw clamps, rivets, nuts andbolts, toggles, pins and the like. Components may also be connected bywelding, brazing, friction fitting, adhesives, or deformation, ifappropriate. Unless specifically otherwise disclosed or taught,materials for making components of the present invention were selectedfrom appropriate materials, such as metal, metallic alloys, fibers,polymers and the like, and appropriate manufacturing or productionmethods including casting, extruding, molding and machining may be used.In addition, any references to front and back, right and left, top andbottom and upper and lower were intended for convenience of description,not to limit the present invention or its components to any onepositional or spatial orientation. Therefore, it is desired that theembodiments described herein be considered in all respects asillustrative, not restrictive, and that reference be made to theappended claims for determining the scope of the invention.

Although the present invention has been described with reference toillustrative embodiments, persons skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

1. An apparatus for insertion into a vessel-like structure, theapparatus comprising: a catheter for insertion into the vessel-likestructure, the catheter having a catheter wall and a lumen extendinglongitudinally therethrough; a moveable member disposed within thelumen; at least one helically twisted flexible strut fixedly connectedto the catheter wall and to the moveable member; and a membrane operablyconnected to the at least one flexible strut to form a trap, whereinrelative motion between the catheter wall and the moveable memberactuates the trap between a helically twisted contracted position and ahelically twisted expanded position.
 2. The apparatus of claim 1,further comprising a balloon operably connected to the catheter andadapted to compress an obstruction.
 3. The angioplasty device of claim2, wherein the catheter further defines an inflation/deflation lumenfluidly connected to the balloon.
 4. The apparatus of claim 2, wherein:the trap has a distal end; the catheter defines at least one suctionaperture situated between the balloon and the distal end of the trap;and the catheter comprises a suction lumen in operable communicationwith the at least one suction aperture.
 5. The apparatus of claim 1,wherein the helically twisted contracted position forms a waist.
 6. Theapparatus of claim 1, wherein the trap is actuated by relativelongitudinal motion between the catheter wall and the moveable member.7. The apparatus of claim 1, wherein the trap is actuated by relativerotational motion between the catheter wall and the moveable member. 8.The apparatus of claim 1, wherein the trap is actuated by relativerotational and longitudinal motion between the catheter wall and themoveable member.
 9. The apparatus of claim 1, wherein the moveablemember defines a guidewire lumen adapted to slidably receive aguidewire.
 10. The apparatus of claim 1, wherein the guidewire ishollow.
 11. The apparatus of claim 1, wherein the at least one strutforms a profile having a first portion and a second portion, wherein thefirst portion has a first radius of curvature and the second portion hasa second radius of curvature, the first radius of curvature is largerthan the second radius of curvature causing the first portion tocontract first to form a cocoon.
 12. The apparatus of claim 1, whereinthe at least one strut includes a first portion and a second portion.13. The apparatus of claim 12, wherein the first portion is formed to bethinner than the second portion causing the first portion to contractfirst to form a cocoon.
 14. The apparatus of claim 12, wherein the firstportion is formed of a material more resilient than the second portioncausing the first portion to contract first to form a cocoon.
 15. Theapparatus of claim 12, wherein a cross section of the first portion hasa smaller moment of inertia than a cross section of the second portionwith a larger moment of inertia, causing the first portion to contractfirst to form a cocoon.
 16. The apparatus of claim 1, further comprisinga coupling device that selectively couples the trap to the catheterwall.
 17. The apparatus of claim 1, comprising a plurality of helicallytwisted flexible struts.
 18. The apparatus of claim 1, comprising ahandle to provide longitudinal and rotational movement of the moveablemember for actuating the trap.
 19. The apparatus of claim 1, wherein themoveable member is a guidewire having a solid first portion and a secondportion that includes a suction lumen.
 20. The apparatus of claim 4,wherein the suction lumen has a first portion with a first diameter anda second portion with a second diameter, wherein the second diameter islarger than the first diameter.